Non organic insomnia
Conditions
Interventions
Spleen Deficiency Group:Granule of Buzhong Yiqi Tang
Spleen Deficiency with Stomach Heat Syndrome Group:Granule of Bupiwei Xieyinhuo Shengyang Tang
Qi Deficiency Healthy People Group:no treatment
Sponsors
Guangdong Provincial Hospital of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: The Group of insomnia: 1. Conform to the western medicine diagnostic criteria of insomnia; 2. Sleep latency is over 30 minutes, and/or wake up at night more than 2 times per night, and/or the total sleep time<6 hours. Duration of those symptoms are more than 1 months; 3. Conform to the diagnostic criteria of insomnia in TCM; 4. Aged 18 to 55 years old; 5. Stable vital signs, conscious, have certain expression and cognitive ability; 6. Voluntary trial and signed informed consent. The non-insomnia group: 1. Conformed to the standard of spleen and stomach qi deficiency corporeity; 2. No significant organic diseases or psychosis and sleep disorders; 3. Aged 18-55 years old; 4. Have certain expression and cognitive ability; 5. Voluntary trial and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Does not conform to the inclusion criteria; 2. Pregnant or lactating patients; 3. Infection and fever in the last week; 4. Participated in other clinical trials in the past three months; 5. Previous history of gastrointestinal disease or gastrointestinal surgery.Patients with severe primary diseases such as cardiovascular, pulmonary, liver, kidney and hematopoietic systems; 6. Insomnia comorbid depression, anxiety, schizophrenia, mania, the standard score of SAS is=60, the standard score of SDS is=62; 7. Patients with a history of epilepsy, OSAHS, COPD, bipolar disorder, mental retardation, cognitive impairment, restless legs syndrome, etc.; 8. Within 6 months, use antibiotics, corticosteroids,immunomodulator , flora regulator and other drugs; 9. In the past 2 weeks, use sedative hypnotics, antipsychotic drugs,gastrointestinal motility drugs, laxative, antidiarrheal agent and other drugs; 10. BMI =28kg/m2 or BMI18.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSQI reduction rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| SAS;SDS;the level of blood cortisol;Composition and proportion of intestinal flora;IL-1ß;IL-6;TNF-a;IFN;IL-10;TNF-ß; | — |
Countries
China
Contacts
Public ContactLi Yan
Guangdong Provincial Hospital of TCM
Outcome results
None listed